Chemoradiation Plus Iparomlimab Consolidation in Older With ESCC

NCT07038629 | Recruiting Phase 2

• 1 other identifier: E20250418
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted in elderly (≥70 years old) patients with locally advanced esophageal squamous cell carcinoma (ESCC). Aim to evaluate the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiation with S-1 in elderly patients with unresectable locally advanced ESCC. Concurrent chemoradiation is the standard treatment for elderly esophageal cancer. However, the overall prognosis of patients still needs to be further improved. The emergence of immune checkpoint inhibitors has brought new hope for patients with ESCC. Iparomlimab can target both PD-1 and CTLA-4 immune inhibitory pathways simultaneously. Studies have shown that it can significantly improve the prognosis in the treatment of ESCC and has good tolerability. In elderly patients with ESCC, concurrent chemoradiation may potentially carry the risk of low treatment completion rate and significant toxicity. Therefore, this study aims to explore the efficacy and safety of Iparomlimab consolidation therapy following concurrent chemoradiotherapy in elderly patients with unresectable locally advanced ESCC. In the study, the investigators plan to enroll 52 elderly subjects with locally advanced ESCC. After receiving radiotherapy combined with the S-1 regimen, patients will enter the screening period. The enrolled patients will receive Iparomlimab consolidation therapy for 1 year. The treatment efficacy and safety will be evaluated.

Conditions

Esophageal Cancer

Keywords

Old Age; Esophageal Cancer; Iparomlimab; Chemoradiation

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  up to 2 years

Secondary Outcomes (6)

• OS

  up to 2 years

• ORR

  up to 2 years

• DoR

  up to 2 years

• AEs

  up to 2 years

• QoL

  up to 2 years

Study Arms (1)

Chemoradiation Plus Iparomlimab Consolidation

EXPERIMENTAL

S1 + Radiotherapy+ Iparomlimab Consolidation: Chemotherapy: S1 PO, 40\~60mg，BID（d1-14，d22-35，two cycles); Radiation: Concurrent Radiation, 1.8Gy/f, 28f; Iparomlimab Consolidation: Iparomlimab IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)

Drug: S1; Drug: Iparomlimab; Radiation: Radiation

Interventions

S1 DRUG

PO, 40\~60mg，BID（d1-14，d22-35，two cycles)

Chemoradiation Plus Iparomlimab Consolidation

Iparomlimab DRUG

IV infusion, 5mg/kg, q3w (Started within 8 weeks of completion of radiation)

Chemoradiation Plus Iparomlimab Consolidation

Radiation RADIATION

Concurrent Radiation, 1.8Gy/f, 28f;

Chemoradiation Plus Iparomlimab Consolidation

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Volunteered to participate, cooperated with follow-up visits;
• Aged ≥ 70 years, both male and female;
• Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1(supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC );
• Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
• Initial treatment: definitive concurrent chemoradiotherapy (radiotherapy: total dose 50.4 Gy, delivered in 28 fractions, 1.8 Gy per fraction, 5 times per week; chemotherapy: S-1: 40-60mg, BID, d1-14, d22-35, for a total of 2 cycles).
• Radiotherapy: completed ≥ 25 fractions or more (i.e., radiotherapy dose ≥ 45 Gy), S-1chemotherapy: completed at least one cycle (d1-14);
• Haven't received any previous systemic anti-tumor therapy before radiotherapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational treatment drugs);
• ECOG performance status 0 or 1;
• Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \[FFPE\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
• Expected survival of ≥ 3 months.
• The function of major organs meets the following requirements:
• Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L;
• Platelets ≥ 100×10\^9/L;
• Hemoglobin ≥ 9g/dL;
• Serum albumin ≥ 2.8g/dL;

You may not qualify if:

• Surgery for esophageal cancer;
• Esophageal fistulae due to infiltration of the primary tumor；
• Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
• Patients who developed ≥ grade 2 pneumonia after concurrent chemoradiotherapy with S-1;
• Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
• Major surgery or severe trauma within 4 weeks prior to first use of study drug;
• Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• Received or receiving any of the following treatments in the past:
• Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
• Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
• Systemic treatment with corticosteroids (\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the esophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor. Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \>10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
• Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
• Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
• Diagnosis of immunodeficiency, including positive HIV test, other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
• Diagnosis of uncontrolled cardiac clinical symptoms or disease such as: a. NYHA II or above heart failure; b. unstable angina; c. myocardial infarction within 1 year; d. clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• Tianjin Medical University Cancer Institute and Hospital: lead
• Shanxi Province Cancer Hospital: collaborator

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination); Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Wencheng Zhang, M.D.

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wencheng Zhang, M.D.

CONTACT

02223340123; zhangwencheng@tjmuch.com

Linrui Gao, M.D.

CONTACT

02223340123

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 26, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)